Oral administration or application of pharmaceutical formulations comprising an active pharmaceutical ingredient with an unpleasant taste remains a technical challenge. In particular, children show a very bad compliance towards bitter formulations. Taste masked formulations have been developed to improve patient compliance.
However, taste-masked formulations typically only work well for solid dosage forms. If liquid drug mixtures are used or in the case of high doses, i.e. large amounts of substance to be swallowed, taste-masked formulations typically do not work satisfactory.
In WO 97/03634, a delivery system for the oral application of a formulation is described, in which a formulation chamber comprises the formulation retained by a retainer. The device described therein is a pipe forming a chamber, which is sealed by cap and a plug moveable within the pipe. For oral application, one end of the pipe—the inlet—is immersed in liquid, while the other end—the outlet—is applied to the patient's mouth. Comparable to the use of a straw, the patient draws the drink into the pipe and the device allows a fluid to flow through the pipe, while the agent formulation is carried away together with the drink flowing through the pipe. For both, filling of the pipe with the formulation to be administered and emptying of the pipe by the patient, the same end—i.e. the outlet—is used. Further, the moveable plug moves through the pipe together with the flow entering into the pipe. Both ends of the pipe are crimped for preventing the release of the moveable plug.
For consummation, a cap has to be removed from one end in order to enable the active agent to be drawn through the opened end. In particular in case of incorrect use, for example by tilting or shaking the pipe, at least a part of the active agent can be lost.
Other prior art systems also relate to pipes comprising a composition to be administered as well as a shiftable block element, which is shifted when the composition is applied. Other solutions provide elements, which are deformed by water (without being dissolved) for releasing an agent from a chamber. Another group of solutions is based on a grid-like blocking element, which holds back the composition to be administered, until the complete composition is dissolved and can be transported through the grid. Finally, systems are known comprising a blocking element which can be removed by hand before use.
Firstly, these systems all suffer from the disadvantage described above, i.e. the release of the composition before the administration to a patient involving the risk of losing a part of the active agent. This falsifies the dose provided to the patient. As a second disadvantage, all delivery systems provide both, a chamber for the composition to be administered as well as means for transporting the composition (distributed within a liquid) to the patient's mouth. In known systems for oral delivery the function of storing and delivering the composition (more exactly: the composition together with the liquid), the dimensions of the systems cannot be scaled down. Beyond a certain minimum dimension, the operation and handling of the system is difficult, which establishes an inherent limit for minimizing the dimensions and an inherent limit to the packaging density. For example, if the length of the pipe is less than 3 cm, it is difficult for a person to move the delivery system to a glass filled with a drink and, at the same time, introducing the other end of the delivery system into the mouth. Since the delivery system is provided for exactly one application rate, packages with a number of dosages become large, and by far larger than packages of other pharmaceutical products. If a package is required to cover one month of a pharmaceutical substance, which has to be administered twice per day, the package size is not comparable with package sizes of the same product in another form.
As a further important disadvantage, conventional delivery systems comprise a relatively complex mechanism, related to high manufacturing costs and a high amount of waste. For example the system of WO 97/03634 comprises as individual elements at minimum (1) a pipe (2) a plug movable within the pipe (3) crimped stoppers at each end of the pipe, (4) a cap and (5) the formulation between plug and cap. This relatively complex system is connected with a complex and costly manufacturing process. All of these elements are special components and are particularly designed for this purpose. In particular, the amount of waste is highly increased in comparison to other common application form like tablets.
It is therefore an object of the invention to provide a device and a process for administering a pharmaceutical substance, which requires low manufacturing costs and provides a higher package density.